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Sub-urethral supporting assembly for treating female stress urinary incontinence

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Publication number
WO2002028312A1
WO2002028312A1 PCT/FR2001/003027 FR0103027W WO2002028312A1 WO 2002028312 A1 WO2002028312 A1 WO 2002028312A1 FR 0103027 W FR0103027 W FR 0103027W WO 2002028312 A1 WO2002028312 A1 WO 2002028312A1
Authority
WO
Grant status
Application
Patent type
Prior art keywords
part
supporting
urethral
means
tape
Prior art date
Application number
PCT/FR2001/003027
Other languages
French (fr)
Inventor
Michel Therin
Original Assignee
Sofradim Production
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/0045Support slings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00805Treatment of female stress urinary incontinence

Abstract

The invention concerns a surgical assembly for supporting the urethra (1) in a woman, comprising a sub-urethral supporting tape (2) and a skin penetrating needle (3). The invention is characterised in that when combined: d) a composite strip (4) assembles at least both the sub-urethral supporting tape (2) and a flattened protective sheath (5) wherein said tape is arranged; e) the flattened sheath (5) comprises, lengthwise, two parts (51, 52) arranged on either side of a separation zone (6) wherein is provided cleavable linking means (7) between the two parts; f) the composite strip (4) comprises at each of its two ends (4a, 4b) a common part (81), for example a female part, of connecting means (8) capable of being locked and unlocked, while the proximal tip (31) of the skin penetrating needle (3) comprises another part (82), for example a male part, of said connection means (8).

Description

ENSEMBLE DE SOUTENEMENT SOUS- URETRAL DANS LE TRAITEMENT DE L'INCONTINENCE URINAIRE D'EFFORT DE LA FEMME La présente invention concerne le traitement chirurgical de l'incontinence urinaire d'effort de la femme. SET OF RETAINING URETHRAL SUB IN THE TREATMENT OF STRESS URINARY INCONTINENCE WOMEN The present invention relates to surgical treatment of stress urinary incontinence in women. Plus particulièrement, l'invention concerne un ensemble chirurgical permettant, au terme de l'intervention ou opération, de soutenir l'urètre au moyen d'une bandelette sous-urétrale, dont les deux extrémités sont chacune attachées à une partie appropriée du corps de la patiente, par exemple à la paroi abdominale de celle-ci. More particularly, the invention relates to a surgical assembly for, after the intervention or operation, to support the urethra by means of a sub-urethral tape, of which both ends are each attached to an appropriate part of the body of the patient, for example the abdominal wall thereof. A cette fin, de manière générale, l'ensemble chirurgical considéré par la présente invention, comprend une bandelette de soutènement sous-urétral et une aiguille de traversée percutanée, cette aiguille permettant l'engagement et le tirage de la bandelette de soutènement sous-urétral. To this end, in general, the surgical assembly contemplated by the present invention comprises a retaining strip suburethral and a percutaneous passage needle, this needle for engaging and pulling the retaining strip suburethral . La présente invention a pour objet un ensemble chirurgical tel que précédemment défini, à caractère universel, en ce sens qu'il peut être utilisé, quelle que soit la voie d'abord, et la technique d'intervention retenue par le praticien. The present invention relates to a surgical assembly as defined above, to universal, in that it can be used regardless of the way first, and intervention technique used by the practitioner.

A cette fin, un ensemble chirurgical selon invention présente en combinaison les caractéristiques suivantes : a) il comprend une bande composite qui rassemble au moins la bandelette de soutènement sous urétrale et une gaine aplatie de protection, ladite bandelette étant disposée, par exemple librement, à l'intérieur de cette gaine ; To this end, a surgical assembly according to the invention presents in combination the following features: a) it comprises a composite band which includes at least the retaining suburethral tape and a flat protective sheath, the said strip being arranged, for example freely, inside this sheath; b) la gaine aplatie comprend, selon sa longueur, deux parties disposées de part et d'autre d'une zone de séparation, dans laquelle est disposé un moyen de liaison sécable entre les deux dites parties ; b) the flat sheath comprises, along its length, two parts arranged on either side of a separation zone in which is arranged a breakable connecting means between said two parts; c) la bande composite comprend à chacune de ses deux extrémités une même partie, par exemple une même partie femelle, d'un moyen de connexion, verrouillable et déverrouillable, tandis que le talon proximal de l'aiguille de traversée percutanée comprend une autre partie, par exemple une partie mâle, dudit moyen de connexion. c) the composite web includes at each of its two ends one part, for example the same female part, a connecting means, locked and unlocked, while the proximal heel of the percutaneous passage needle comprises another part , for example a male part, of said connecting means.

Pour l'une des voies retenues par le chirurgien, par exemple la voie haute, l'ensemble comprend en outre et éventuellement une pièce plate et souple, atraumatique, de jonction de deux morceaux de la bandelette de soutènement, obtenus par découpe transversale de cette dernière. For one of the channels selected by the surgeon, for example the high channel, the assembly further comprises and optionally a flat, flexible piece, atraumatic, joining two pieces of the retaining strip, obtained by transverse cutting of this last. Et cette pièce de jonction comprend deux moyens opposés de préhension de deux extrémités adjacentes des deux morceaux respectivement de la bandelette de soutènement. And this connecting piece comprises two opposite gripping means of two adjacent ends of two pieces of the retaining strip respectively.

La présente invention est maintenant décrite par référence au dessin annexé, dans lequel : - La figure 1 représente, vu de face, un ensemble chirurgical selon l'invention, The present invention is now described with reference to the accompanying drawing, wherein: - Figure 1 shows a front view of a surgical assembly according to the invention,

- La figure 2 représente, vu de côté, l'ensemble chirurgical représenté à la figure 1 , - Figure 2 shows a side view of the surgical assembly illustrated in Figure 1,

- La figure 3 représente, vue en coupe, un moyen de connexion avec l'aiguille de traversée percutanée, appartenant à l'ensemble chirurgical représenté selon les figures 1 et 2, - Figure 3 shows, in sectional view, a connection means with the percutaneous passage needle, belonging to the surgical assembly illustrated according to Figures 1 and 2,

- La figure 4 représente, vue de dessus, une pièce de jonction de deux morceaux de la bandelette de soutènement, pouvant appartenir à un ensemble chirurgical selon invention, - La figure 5 représente, vue de côté, la pièce de jonction représentée à la figure 7, avec ses deux moyens opposés de préhension en position ouverte, - Figure 4 shows, in top view, a joining part of two pieces of the support strip, which may belong to one surgical assembly according to the invention, - Figure 5 represents a side view of the junction piece shown in Figure 7 with its two opposite gripping means in the open position,

- Les figures 6 à 9 représentent les différentes étapes de mise en place ou mise en œuvre d'un ensemble chirurgical selon l'invention, par la voie basse, - Figures 6 to 9 show the various stages of implementation or implementation of a surgical assembly according to the invention, by vaginally,

- Les figures 10 à 13 représentent les différentes étapes de mise en en place ou mise en œuvre d'un ensemble chirurgical selon l'invention, par une voie dite mixte, - Figures 10 to 13 show the different stages of setting up or implementation of a surgical assembly according to the invention, by a so-called mixed path,

- Les figures 14 à 21 représentent les différentes étapes de mise en en place ou mise en œuvre d'un ensemble chirurgical selon l'invention, par la voie haute. - Figures 14 to 21 show the different stages of setting up or implementation of a surgical assembly according to invention, by the high way.

Conformément aux figures 1 à 3, un ensemble chirurgical selon l'invention comprend au minimum : In accordance with Figures 1 to 3, a surgical assembly according to the invention comprises at least:

- une bande composite 4 comportant deux extrémités 4a, 4b effilées, de forme triangulaire, à plat, - a composite strip 4 having two ends 4a, 4b tapered, triangular, flat,

- et une aiguille 3 de traversée percutanée comportant une extrémité distale 32 de pénétration et un talon proximal aplati 31 - and a needle 3 by percutaneous passage having a distal end 32 of penetration and a flattened proximal heel 31

La bande composite 4 rassemble au moins, une bandelette 2 de soutènement sous-urétral, deux embouts 9, et une gaine 5 aplatie de protection, à l'intérieur de laquelle la bandelette 2 est disposée librement, c'est-à-dire sans être attachée à la gaine 5. La bandelette 2 de soutènement comprend un tricot ajouré, de préférence indémaillable, obtenu avec des monofilaments ou multifilaments en matériau synthétique biocompatible, par exemple en polypropylène ou polyester. The composite web 4 brings at least a strip 2 retaining suburethral, ​​two end pieces 9, and a flat protective sheath 5, within which the strip 2 is arranged freely, that is to say without be attached to the duct 5. the strip 2 comprises a retaining apertured tricot, preferably indémaillable obtained with monofilaments or multifilaments of a biocompatible synthetic material, for example polypropylene or polyester. La bandelette 2 est de préférence formée à partir d'un matériau tricoté macro poreux. The strip 2 is preferably formed from a knitted material macroporous.

Ce dernier est par exemple un tricot ajouré en monofil de polypropylène ayant une grosseur comprise entre 0,12 et 0,16 millimètre et composé de deux nappes formées par deux barres à passettes enfilées chacune, une passette pleine-une passette vide, ces deux barres étant déplacées symétriquement en mailles ouvertes suivant le barème suivant : The latter is for example an apertured knitted polypropylene monofilament having a size between 0.12 and 0.16 millimeter and composed of two layers formed by two threaded guide bars each one full-empty eye needle heddle hook, these two bars being displaced symmetrically open mesh according to the following scale:

- barre I : 01-12-32 - bar I: 01-12-32

- barre II : 32-21-01 - Bar II: 32-21-01

La bandelette 2 est découpée en longueur dans le sens de la chaîne du tricot. The strip 2 is cut to length in the warp direction of the knitted fabric. Dans le cas d'une largeur de 12 mm, elle présente les caractéristiques suivantes : In the case of a width of 12 mm, it has the following characteristics:

- une résistance à la rupture dans le sens de la chaîne de 105N +. - a tensile strength in the direction of 105N + chain. 20 %, 20%

- un allongement à la rupture dans le sens de la chaîne de 92 % _+ 20 %, - an elongation at break in the warp direction of 92% _ + 20%,

- un allongement sous 20N de 36 %, - an elongation at 20N 36%

- un début de tuilage avec une force de 6N et un allongement de 15 %. - a start tiling with 6N force and an elongation of 15%.

Par "tuilage", on entend l'enroulement spontané de la bandelette 2 sur elle-même, autour de son axe longitudinal, sous contrainte en tension longitudinale. By "tiling", spontaneous winding means of the strip 2 on itself about its longitudinal axis under longitudinal tensile stress.

La bandelette 2présente des avantages intéressants et en particulier une faible émission de particules lors de son étirement, ainsi qu'un tuilage qui n'apparaît que sous une force importante (6N). The strip 2présente interesting advantages, particularly low particulate emissions during its stretching and a curl which appears only as an important force (6N). Toutes ces caractéristiques précitées n'altèrent en rien la porosité de la bandelette 2. All these aforementioned features do not affect the porosity of the strip 2.

Cette dernière peut également être réalisée en tout ou en partie en tissu ou matériau biologique, par exemple en collagène. The latter can also be performed in whole or in part by biological tissue or material, for example collagen.

La gaine de protection 5, aplatie, est obtenu à partir d'un matériau synthétique à faible coefficient de frottement, par exemple en The protective sheath 5, flattened, is obtained from a synthetic material with a low coefficient of friction, for example by

PTFE. PTFE. Cette gaine 5 comprend, selon sa longueur, deux parties 51 et 52 disposées de part et d'autre d'une zone de séparation 6, dans laquelle est disposé un moyen de liaison 7 sécable entre les deux dites parties. This sheath 5 comprises, along its length, two parts 51 and 52 disposed on either side of a separation zone 6 in which is arranged a connecting means 7 breakable between said two parts.

La bande composite 4 comprend à chacune de ses deux extrémités 4a et 4b une même partie, à savoir une même partie femelle 81 , d'un moyen de connexion 8, verrouillable et déverrouillable à volonté, tandis que le talon proximal 31 de l'aiguille 3 de traversée percutanée comprend une autre partie, par exemple une partie mâle 82, du même moyen de connexion 8. The composite strip 4 comprises at each of its two ends 4a and 4b the same part, namely one female part 81, a connection means 8, locked and unlocked at will, while the proximal heel of the needle 31 3 percutaneous passage includes another portion, for example a male part 82, the same connecting means 8.

A cette fin, la gaine aplatie 5 comprend ou incorpore, à ses deux extrémités respectivement, deux embouts 9, comprenant ou incorporant, à l'extérieur de la gaine 5, chacun la même partie femelle 81 du moyen de connexion 8. To this end, the flattened sheath 5 includes or incorporates, at its two ends, two end pieces 9, comprising or incorporating, on the outside of the sheath 5, each of the same female part 81 of the connecting means 8.

Ce moyen de connexion 8 comprend donc deux éléments, l'un mâle 82 situé à chaque extrémité 4a ou 4b de la bande composite,. This connecting means 8 therefore comprises two elements, one male 82 located at each end 4a or 4b of the composite strip ,. , et l'autre femelle 81 , situé sur le talon proximal 31 de l'aiguille 3, ces deux éléments mâle et femelle étant encliquetables l'un dans l'autre. And the other female 81, located on the proximal heel 31 of the needle 3, these two male and female elements being snap one into the other.

Plus précisemment, comme montré en particulier par la figure 3, le talon proximal 31 de l'aiguille 3 de traversée cutanée est spatule, et chaque embout 9 de la bande composite 4 comprend, à l'extérieur de la gaine aplatie 5, une fente 83 adaptée pour la pénétration du talon proximal spatule 31 de l'aiguille 3, avec un moyen 84 de retenue du talon 31 , verrouillable ou déverrouillable manuellement. More precisely, as shown particularly by Figure 3, the proximal heel 31 of the needle through skin 3 is spatula, and each end piece 9 of the composite tape 4 comprises, outside of the flattened sheath 5, a slot 83 adapted to the penetration of the proximal heel tip 31 of the needle 3, with a means 84 of heel retainer 31, lockable or releasable manually. Le talon proximal 31 de l'aiguille 3 comprend une fente traversante 85, pour la pénétration élastique du moyen de retenue 84. Conformément à la figure 1 , et selon un mode particulier de réalisation, le moyen de liaison 7 sécable consiste en un fourreau extérieur The proximal heel 31 of the needle 3 comprises a through slot 85 for the elastic penetration of the retention means 84. In accordance with Figure 1, and according to a particular embodiment, the breakable connecting means 7 consists of an outer sheath

71 , adhésif, déchirable, par exemple par cisaillement, au moyen d'un onglet 71, adhesive, tear, for example by shearing, by means of a tab

72. Ce fourreau 71 rassemble deux extrémités intérieures 51 a et 52a des deux parties 51 et 52 de la gaine aplatie 5, respectivement adjacentes à la zone de séparation 6. 72. This sleeve 71 brings together two inner ends 51a and 52a of the two parts 51 and 52 of the flattened sheath 5 respectively adjacent to the separation zone 6.

Pour la voie d'intervention dite haute, décrite ci-après, l'ensemble chirurgical comprend en outre une pièce 10 représenté aux figures 4 et 5, adaptée pour joindre deux morceaux 21 et 22 de la bandelette 2 de soutènement (cf figures 18 à 21 ), obtenus par découpe transversale de cette dernière. To the route of said high response, as described below, the surgical assembly further comprises a part 10 shown in Figures 4 and 5, suitable for joining two pieces 21 and 22 of the strip 2 of support (see Figures 18 to 21), obtained by transverse cutting of the latter. Cette pièce 10 de jonction, atraumatique, plate et souple, comprend deux moyens opposés de préhension, de deux extrémités adjacentes 21a et 22a de deux morceaux 21 et 22 respectivement. This part 10 of junction, atraumatic, flat and flexible, comprises two opposite gripping means, two adjacent ends 21a and 22a of two pieces 21 and 22 respectively. A cette fin, chaque moyen 1 1 de préhension comprend, d'une part un moyen de serrage 12 d'une extrémité 21a ou 22a (cf figures 18 à 21 ) de la bandelette 2 de soutènement, constitué par deux mâchoires plates 12a et 12b articulées selon une même ligne de liaison, et d'autre part un moyen 13 d'agrafage de la même extrémité, consistant en un pion 13a sur l'une 12b des mâchoires, pour traverser la bandelette 2, et une tête 13b disposée sur l'autre mâchoire 12a, encliquetable sur le pion 13a. To this end, each gripping Average Rating 1 1 comprises, first clamping means 12 a or 21a end 22a (see Figures 18 to 21) of the strip 2 of support, consisting of two jaws 12a and 12b flat hinged along the same connecting line, and secondly means 13 stapling the same end, consisting of a pin 13a on one of the jaws 12b, to pass through the strip 2, and a head 13b disposed on the the other jaw 12a, snap on the pin 13a.

Trois modes différents de mise en place ou mise en œuvre de l'ensemble chirurgical décrit précédemment sont maintenant exposés, à savoir respectivement un mode dit par voie basse, un mode dit par voie mixte, et un mode dit par voie haute. Three different modes of implementation or implementing the surgical assembly described above are now exposed, namely a mode called vaginal respectively, a mode called a mixed way and a mode called by high way. Pour chacun de ces modes, on part de l'ensemble chirurgical, selon figures 1 à 3, dans sa position connectée ou verrouillée, dans laquelle l'aiguille 3 est connectée par son talon proximal 31 , avec l'un des embouts 9, c'est-à-dire à l'une des extrémités, par exemple 4a, de la bande composite 4, et ce, grâce au moyen de connexion 8 précédemment décrit. For each of these modes, one starts from the surgical assembly according to Figures 1 to 3, in its connected or locked position, wherein the needle 3 is connected with its proximal bead 31, with one of the end pieces 9, c that is to say at one end, for example 4a, the composite web 4, and, thanks to the connecting means 8 previously described. S'agissant du mode dit par voie basse, et en se référant aux figures 6 à 9 : For Mode said vaginally, and with reference to Figures 6 to 9:

- en introduisant l'aiguille 3 par le vagin 17, on fait pénétrer l'aiguille 3 de bas en haut, du côté droit du patient, en contournant la vessie 16 ; - introducing the needle 3 through the vagina 17, is made to penetrate the needle 3 from bottom to top, the patient's right side, bypassing the bladder 16; cf figure 6. - on engage ainsi la bande composite 4 dans le trajet droit ; see Figure 6. - thus engages the composite strip 4 in the right path; cf figure 7. cf Figure 7.

- on déconnecte l'aiguille 3 de l'extrémité 4a de la bande composite 4, pour la connecter à l'extrémité 4b de la même bande ; - disconnecting the needle 3 of the end 4a of the composite strip 4 to connect it to the end 4b of the same band; puis on fait pénétrer l'aiguille 3 de bas en haut, du côté gauche du patient, toujours en contournant la vessie 16 ; then is made to penetrate the needle 3 from bottom to top, the patient's left side, still bypassing the bladder 16; cf figure 8. see Figure 8.

- on engage ainsi la bande composite 4 dans le trajet gauche ; - thus engages the composite strip 4 in the left path; lorsque cette dernière forme une boucle à l'extérieur du vagin 17, on déchire transversalement par cisaillement le moyen de liaison 7, pour libérer les deux parties 51 et 52 de la gaine 5 ; when the latter forms a loop outside of the vagina 17, is torn transversely by shearing the connecting means 7, to release the two parts 51 and 52 of the sheath 5; en tirant sur les deux embouts 9, on extrait les deux parties 51 et 52 de la gaine 5, et on libère la bandelette de soutènement 2, au-dessous de l'urètre 1. S'agissant de la voie mixte, et en se référant aux figures 10 à 13 : by pulling on the two end pieces 9, extract the two parts 51 and 52 of the sheath 5, and releasing the retaining strip 2, below the urethra 1. With respect to the mixed path, and by referring to figures 10 to 13:

- on fait pénétrer l'aiguille 3 de haut en bas, du côté droit du patient, en contournant la vessie 16, et en ressortant par le vagin 17 ; - is made to penetrate the needle 3 from top to bottom, the patient's right side, bypassing the bladder 16, and emerging through the vagina 17; cf la figure 10 ; cf Figure 10;

- on engage ensuite la bande composite 4 dans le trajet droit, par pénétration de l'aiguille 3 de bas en haut, du côté gauche, en contournant la vessie 16 ; - the composite strip is then engaged 4 in the straight path, by penetration of the needle 3 from bottom to top, left side, bypassing the bladder 16; cf figure 11 ; cf Figure 11;

- on engage ainsi la bande composite 4 dans le trajet gauche ; - thus engages the composite strip 4 in the left path; on déconnecte l'aiguille 3 de la bande composite 4 ; disconnecting the needle 3 of the composite strip 4; on déchire transversalement le moyen de liaison 7, par cisaillement du fourreau extérieur 71 , et on extrait de ce dernier à l'extérieur du vagin 17 (cf figure 12) ; is torn transversely connecting means 7, by shearing of the outer sleeve 71, and extracted from the latter to the outside of the vagina 17 (see Figure 12);

- par traction sur les deux embouts 9, on extrait les deux parties 51 et 52 de la gaine 5, et on libère la bandelette 2 de soutènement dans son trajet. - by pulling on the two end pieces 9, extract the two parts 51 and 52 of the sheath 5, and releasing the retaining strip 2 on its way.

S'agissant de la voie haute, et en se référant aux figures 14 à 21 : As regards the high way, and with reference to Figures 14 to 21:

- on fait pénétrer l'aiguille 3 de haut en bas, du côté droit du patient, à partir de la paroi abdominale 15, en contournant la vessie 16, et en ressortant par le vagin 17 (cf figure 14) ; - is made to penetrate the needle 3 from top to bottom, the patient's right side, from the abdominal wall 15, bypassing the bladder 16, and emerging through the vagina 17 (see Figure 14);

- on engage ainsi la bande composite 4 dans le trajet droit ; - thus engages the composite strip 4 in the right path; lorsque le moyen de liaison 7 est à l'extérieur du vagin 17, on coupe la bande composite 4 de part et d'autre de ce dernier, de manière à déterminer deux parties, une partie 41 demeurant dans le trajet droit, et une partie 42 à l'extérieur du vagin 17 (cf figure 15) ; where the binding means 7 is outside the vagina 17, cutting the composite strip 4 on both sides of the latter, so as to determine two parts, one part 41 remaining in the straight path, and a part 42 outside the vagina 17 (see Figure 15);

- on fait ensuite pénétrer l'aiguille 3 connectée à la partie 42 de la bande composite 4, de haut en bas à partir de la paroi abdominale 15, du côté gauche, en contournant la vessie 16 (cf figure 16) ; - is then made to penetrate the needle 3 connected to the portion 42 of the composite web 4, from top to bottom from the abdominal wall 15, the left side, bypassing the bladder 16 (see Figure 16); - on engage ainsi la partie 42 de la bande composite 4 dans le trajet gauche puis on coupe la portion émergente de la partie 42 de la bande composite 4, de manière à séparer l'embout 9 correspondant du reste de la bande 4 (cf figure 17) ; - thus engages the portion 42 of the composite strip 4 in the left path and then cutting the emerging part of the portion 42 of the composite strip 4, so as to separate the end piece 9 matching the rest of the web 4 (see Figure 17);

- en tirant sur les extrémités 21 a et 22a de la bandelette 2 de soutènement, on dénude ces dernières par rapport aux deux parties 52 et - by pulling on the ends 21a and 22a of the two strip retaining, it strips off the latter relative to both parts 52 and

51 respectivement de la gaine 5 ; 51 respectively of the sheath 5; on peut ainsi présenter la pièce 10 de jonction, et procéder à la préhension des deux extrémités 21 a et 22a (cf figure 18) ; can thus have the junction piece 10, and proceed with the gripping of the two ends 21a and 22a (see Figure 18);

- la pièce 10 de jonction réunit ainsi, de manière sécurisée, les deux extrémités 21a et 22a de la bandelette de soutènement 2, à l'extérieur du vagin 17, comme montré à la figure 19 ; - the junction piece 10 thus combines, in a secure way, both ends 21a and 22a of the retaining strip 2 outside the vagina 17, as shown in Figure 19;

- puis on procède à une traction suspubienne sur les parties droite 41 et gauche 42 de la bande composite 4, de façon à amener la pièce 10 de jonction en position sous-urétrale : puis on tire sur les deux parties 52 et 51 de la gaine 4, de façon à libérer la bandelette de soutènement 2 ; - then one proceeds to a suprapubic traction on the right portions 41 and left 42 of the composite strip 4, so as to bring the part 10 of junction suburethral position: then pulls on the two portions 52 and 51 of the sheath 4, so as to release the retaining strip 2; cf figure 20. see figure 20.

- la bandelette 2 se trouve ainsi en position rétropubienne et para-vésicale, tandis que la pièce 10 de jonction, atraumatique, se trouve en position sous-urétrale (cf figure 21 ). - the strip 2 is thus in retropubic position and para-vesical, while the junction piece 10, atraumatic, is sub-urethral position (see Figure 21).

Comme décrit précédemment, on constate qu'un ensemble chirurgical selon l'invention peut être utilisé quelle que soit la voie d'abord, et la technique d'intervention choisie par le chirurgien. As described above, there is a surgical assembly according to the invention can be used regardless of the surgical approach and technique of intervention chosen by the surgeon.

Grâce à l'invention, la bandelette 2 de soutènement peut être libérée au dernier moment, après vérification des trajets par cystoscopie. Thanks to the invention, the strip 2 retaining can be released at the last moment, after verification of trips by cystoscopy.

En cas de trajet erroné, lors du premier passage et/ou lors du second passage, la procédure d'intervention demeure réversible, soit par déconnection de l'aiguille 3 et traction rétrograde de la gaine 5, soit par traction complète de la bande composite 4. If a wrong path, during the first pass and / or in the second pass, the interventional procedure remains reversible, either by disconnection of the needle 3 and pulling retrograde sheath 5, either by complete pulling of the composite web 4.

Tant que la gaine 5 n'est pas séparée en ses deux parties 51 et 52, l'ensemble chirurgical selon l'invention est réutilisable autant de fois que nécessaire, et ce jusqu'à ce que le trajet souhaité soit obtenu. As the sheath 5 is not separated into its two parts 51 and 52, the surgical assembly according to the invention is reusable many times as necessary, until the desired path is achieved.

Claims

REVENDICATIONS CLAIMS
1 - Ensemble chirurgical pour soutenir l'urètre (1 ) chez la femme, comprenant une bandelette (2) de soutènement sous-urétral et une aiguille (3) de traversée percutanée, caractérisé, en combinaison : a) en ce qu'il comprend une bande composite (4) qui rassemble au moins la bandelette (2) de soutènement sous urétral et une gaine (5) aplatie de protection, ladite bandelette (2) étant disposée, par exemple librement, à l'intérieur de cette gaine (5) ; 1 - to support the urethra surgical assembly (1) in women, comprising a strip (2) for sub-urethral support and a needle (3) of percutaneous passage, characterized, in combination: a) in that it comprises a composite band (4) that gathers at least the strip (2) of support under urethral and a sheath (5) of flattened protection, said strip (2) being arranged, for example freely, inside this sheath (5 ); b) la gaine (5) aplatie comprend, selon sa longueur, deux parties b) the sheath (5) comprises flattened, along its length, two parts
(51 , 52) disposées de part et d'autre d'une zone de séparation (6), dans laquelle est disposé un moyen de liaison (7) sécable entre les deux dites parties ; (51, 52) arranged on either side of a separation zone (6) in which is arranged a connecting means (7) breakable between said two parts; c) la bande composite (4) comprend à chacune de ses deux extrémités (4a, 4b) une même partie (81 ), par exemple une même partie femelle, d'un moyen de connexion (8), verrouillable et déverrouillable, tandis que le talon proximal (31 ) de l'aiguille (3) de traversée percutanée comprend une autre partie (82), par exemple une partie mâle, dudit moyen de connexion (8). c) the composite band (4) comprises at each of its two ends (4a, 4b) one portion (81), for example the same female part, a connecting means (8), locked and unlocked, while the proximal heel (31) of the needle (3) of percutaneous passage includes another portion (82), for example a male part, of said connecting means (8). 2 - Ensemble selon la revendication 1 , caractérisé en ce que la bande composite (4) comprend deux embouts (9) comprenant ou incorporant chacun ladite même partie (81 ) du moyen de connexion (8). 2 - assembly of claim 1, characterized in that the composite band (4) comprises two endpieces (9) comprising or incorporating each said same portion (81) of the connecting means (8).
3 - Ensemble selon la revendication 1 , caractérisé en ce que le moyen de connexion (8) comprend deux éléments, l'un mâle (82) et l'autre femelle (81 ) encliquetables l'un dans l'autre. 3 - assembly of claim 1, characterized in that the connecting means (8) comprises two elements, one male (82) and the other female (81) snap into one another.
4 - Ensemble selon la revendication 3, caractérisé en ce que le talon proximal (31 ) de l'aiguille (3) de traversée cutanée est spatule et chaque embout (9) de la gaine aplatie (5) comprend une fente (83) adaptée pour la pénétration dudit talon proximal spatule (31 ), avec un moyen de retenue (84) dudit talon, verrouillable ou déverrouillable manuellement. 4 - assembly of claim 3, characterized in that the proximal heel (31) of the pin (3) skin is traversed and each spatula tip (9) of the flat sheath (5) comprises a slot (83) adapted for penetration of said spatula proximal heel (31), with retaining means (84) of said heel, lockable or releasable manually.
5 - Ensemble selon la revendication 4, caractérisé en ce que le talon proximal (31 ) de l'aiguille de traversée cutanée (3) comprend une fente traversante (85) pour la pénétration du moyen de retenue (84). 5 - assembly of claim 4, characterized in that the proximal heel (31) of skin crossing needle (3) comprises a through slot (85) for the penetration of the retention means (84).
6 - Ensemble selon la revendication 1 , caractérisé en ce que le moyen de liaison (7) sécable, comprend un fourreau extérieur (71 ) adhésif, par exemple déchirable par cisaillement, rassemblant les deux extrémités intérieures (51a, 52a) des deux parties (51 , 52) de la gaine aplatie (5), respectivement adjacentes à la zone de séparation (6). 6 - assembly according to claim 1, characterized in that the connecting means (7) scored, comprises an outer sheath (71) adhesive, e.g. tearable shear, bringing together the two inner ends (51a, 52a) of the two parts ( 51, 52) of the flat sheath (5) respectively adjacent to the separation zone (6).
7 - Ensemble selon la revendication 1 , caractérisé en ce qu'il comprend, en outre, une pièce (10) plate et souple de jonction de deux morceaux (21 , 22) de la bandelette (2) de soutènement, obtenus par découpe transversale de cette dernière, ladite pièce comprenant deux moyens opposés (1 1 ) de préhension des deux extrémités adjacentes (21a, 22a) des deux morceaux respectivement. 7 - assembly of claim 1, characterized in that it further comprises a part (10) flat and flexible joining two pieces (21, 22) of the strip (2) of support, obtained by transverse cutting of the latter, said part comprising two opposite means (1 1) for gripping the two adjacent ends (21a, 22a) of the two tracks respectively.
8 - Ensemble selon la revendication 7, caractérisé en ce que chaque moyen (1 1 ) de préhension comprend un moyen de serrage (12) d'une extrémité (21 a, 22a) de la bandelette (2) de soutènement. 8 - assembly of claim 7, characterized in that each means (1 1) for gripping comprises a clamping means (12) one end (21a, 22a) of the strip (2) of support.
9 - Ensemble selon la revendication 7, caractérisé en ce que chaque moyen (1 1 ) de préhension comprend un moyen (13) d'agrafage d'une extrémité (21 a, 22a) de la bandelette (2) de soutènement, par exemple un pion (13a) pour traverser la bandelette avec une tête (13b) encliquetable sur ledit pion. 9 - assembly of claim 7, characterized in that each means (1 1) comprises gripping means (13) for stapling an end (21a, 22a) of the strip (2) of support, e.g. a pin (13a) to cross the strip with a head (13b) can be snapped onto said pin.
10 - Ensemble selon la revendication 1 , caractérisé en ce que la bandelette (2) de soutènement comprend un tissu tricoté ajouré indémaillable, obtenu avec des monofilaments ou multifilaments en matériau synthétique biocompatible, par exemple en polypropylène ou polyester. 10 - assembly of claim 1, characterized in that the strip (2) comprises an apertured retaining ladderproof knitted fabric obtained with monofilaments or multifilaments of a biocompatible synthetic material, for example polypropylene or polyester.
1 1 - Ensemble selon la revendication 1 , caractérisé en ce que bandelette de soutènement (2) est réalisée en tout ou en partie en tissu ou matériau biologique, par exemple en collagène. 1 1 - The assembly of claim 1, characterized in that the retaining strip (2) is made in whole or in part by biological tissue or material, for example collagen. 12 - Ensemble selon la revendication 1 , caractérisé en ce que la gaine de protection (5) est obtenue à partir d'un matériau synthétique à faible coefficient de frottement, par exemple en PTFE. 12 - assembly of claim 1, characterized in that the protective sheath (5) is obtained from a synthetic material with a low coefficient of friction, for example PTFE.
PCT/FR2001/003027 2000-10-05 2001-10-01 Sub-urethral supporting assembly for treating female stress urinary incontinence WO2002028312A1 (en)

Priority Applications (2)

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FR0012750A FR2814939B1 (en) 2000-10-05 2000-10-05 Set soutenement sub-urethral in the treatment of urinary incontinence in women effort
FR00/12750 2000-10-05

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DE2001615705 DE60115705T2 (en) 2000-10-05 2001-10-01 Support arrangement at the bottom of the ureters in the treatment of incontinence in women
DE2001615705 DE60115705D1 (en) 2000-10-05 2001-10-01 Support arrangement at the bottom of the ureters in the treatment of incontinence in women
JP2002531942A JP3776083B2 (en) 2000-10-05 2001-10-01 Urethra under the support assembly of the time of treatment of stress urinary incontinence in women
EP20010976344 EP1339347B1 (en) 2000-10-05 2001-10-01 Sub-urethral supporting assembly for treating female stress urinary incontinence
US10151982 US6685629B2 (en) 2000-10-05 2002-05-22 Suburethral support assembly in treatment of female urinary stress incontinence

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JP (1) JP3776083B2 (en)
DE (2) DE60115705D1 (en)
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